MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

Model Number 000000000000081000

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2014

Event Type  malfunction  

Event Description

The customer reported an incident of data input error in the trima system.The customer entered the donor's weight as (b)(6) when the actual weight is (b)(4).Twelve 12 minutes into the donation, the operator ended the procedure when the error was discovered.Patient identifier and age are not available at this time.This report is being filed due to device malfunction, in the form of operator error, that has the potential for injury.

Manufacturer Narrative

Investigation: per the customer, the operator contacted terumo bct's support specialist because the operator noticed the collect volume was higher than what the donor generally donates.The run data file (rdf) was reviewed for this event.Per the rdf none of the safety box was compromised because the procedure was ended early.The ac infusion rate was calculated and found to be less than the safety limit of 1.2ml/min/liter tbv.The donor received 4.2ml/min, and the maximum she could receive was 4.8ml/min.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: no on-site service was performed.A review of the last year of service history for this device indicated no other reports to this issue.The machine has been in use with no further occurrences of the problem.Root cause: the root cause of the reported issue, was the entry of wrong donor information by the user.The machine operated as intended; the reported problem resulted in a fail safe condition.A report of operator error issues is distributed each quarter to sales and implementation for potential targeted training.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3815380
• MDR Text Key: 15181863
• Report Number: 1722028-2014-00175
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000000000000081000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2014
• Initial Date FDA Received: 05/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 73